• Jt095 - Prin Software Quality Engineer

    Quality Consulting Group (Juncos, PR)


    QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

    Responsibilities:

    + Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures.

    + Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation.

    + Defines appropriate measures to ensure product quality.

    + Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives.

    + Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts.

    + Reviews software systems design, changes specifications, and plans against contractual and/or process requirements.

    + Reviews include applicable specifications, materials, tools, techniques, and methodologies.

    + Provides or directs verification and validation of software system requirements, traceability, and testability.

    Qualifications:

    + Bachelor’s degree in Engineering: Mechanical, Electrical or Computer/Software preferred (not Science) or Programming

    + Minimum of 7 years of experience on field (quality – excluding experience laboratory micro/chemistry) or engineering or programming

    + Experience with Risk management documentation: pFMEAs

    + Basic knowledge in PLC, general programming, Source Code Review (e.g. Automation/ Controls / Programming hands on experience)

    + Computer Software validations/GAMP knowledge – hands on experience

    + Basic knowledge in Root Cause Analysis

    + CAPA/ Investigations/ Root Cause Analyses/Technical Writing

    + Basic knowledge in designing validation strategies (e.g requirements flow down from design to manufacturing)

    + Perform and/or review process validation (not cleaning processes) and equipment documents: URS, FAT, IQ, OQ, PQ, TMV (not laboratory)

    + Knowledge in Medical Devices regulations

    + Knowledge in GAMP

    + Shift: 1st and 2nd shift and weekends (it will depend on production schedule – projects will be executed at different time shifts; sometimes on weekends.

     

    Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

     

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